Tissue refining device

ABSTRACT

A device for use in a system or method of collecting and processing aspirated tissue received from a harvesting device is provided by a canister body having a vacuum port and an evacuation port operable to be placed in communication with a vacuum source, a tissue harvesting port for directing tissue into the canister body received from the harvesting device under suction, a pressure equalization passage, and a separator element dividing the canister body into an upper vacuum chamber in communication with the vacuum port and the tissue harvesting port and a lower vacuum chamber in communication with the evacuation port, the separator element including a plurality of apertures enabling fluid to pass between the chambers while restricting tissue from doing the same and a depression with a channel leading to a tissue retrieval port to facilitate processed tissue collection.

This is a continuation-in-part of U.S. Ser. No. 12/470,736, filed on May22, 2009, now U.S. Pat. No. 8,100,874 entitled Tissue Refining Device.

BACKGROUND

1. Field of the Invention

The present invention relates to fluid and tissue collection devices andmore specifically to devices for collecting and processing aspiratedadipose tissue for use in autologous adipose tissue implantationprocedures.

2. Background Art

Liposuction, a popular type of cosmetic surgery also known aslipoplasty, liposculpture and suction assisted body contouring, is atechnique for removing adipose tissue by inserting a hollow tube, orcanula, through the skin and connecting it to a vacuum pump to suctionout a quantity of fatty tissue. The procedure may be used to removeunwanted deposits of excess fat, to improve body appearance, and tosmooth irregular or distorted body shapes, also known as body sculpting.Liposuction may be useful for contouring almost any area of the bodyincluding under the chin, neck, cheeks, upper arms, breasts, abdomen,buttocks, hips, thighs, knees, calves, and ankle areas.

A liposuction machine and special instruments are used for this type ofsurgery. In general, the surgical team first preps the operative siteand administers either local or general anesthesia. Through a small skinincision, a suction tube with a sharp end is inserted into the fatpockets and swept through the area where fat is to be removed. Thedislodged fat is vacuumed away through the suction tube and depositedinto a collection or waste canister. A vacuum pump or a large syringegenerates the negative pressure to aspirate the fatty tissue.

In addition to removing unwanted fat, the harvested fat may bere-introduced back into the patient. This is referred to as adiposetissue transplantation. It is preferred to use the patient's own fattytissue (autologous adipose tissue implantation) since it is more likelyto be accepted. Using the patient's own tissues also reduces or eveneliminates the need for testing for allergic reactions and the fillingreplacement tissue may be permanent. Given the decline and drawbacks inthe use of foreign substances such as synthetic materials like siliconeand teflon as well as the use of foreign tissues such as bovinecollagen, and the advantages of autologous adipose tissue, the interestin and demand for this autologous adipose tissue transplantationcontinues to increase.

Autologous adipose tissue (or fatty tissue) transplantation is performedby many surgeons for various cosmetic and reconstructive procedures,particularly those relating to the face, hands and other areas. Morespecifically, autologous fat transplantation involves retrieving adiposetissue using liposuction techniques from an area of abundance and thenre-injecting the harvested adipose tissue into a different site of thesame individual for cosmetic/reconstructive augmentation or enhancementpurposes. Generally, prior to the re-introduction of the tissue into thepatient, the adipose tissue must be processed or cleaned to maximize thechances of implant survival. Such processing is preferably accomplishedwhile minimizing the exposure of the tissue to air as possible. However,the adipose cells are relatively delicate and the number of steps andlength of time required to separate and process the harvested tissueprior to re-introduction into the patient contributes directly to thesuccess of the operation and decreases the likelihood the tissue will berejected.

The more commonly used aspiration based liposuction techniques includeTumescent Liposuction, Wet and Super-Wet Liposuction, and Power-AssistedLiposuction (PAL). Tumescent liposuction is the most common type ofliposuction. It involves injecting a large amount of medicated solutioninto the areas before the fat is removed. Frequently, the solution maybe up to three times the volume of fat to be removed. The fluid is amixture of local anesthetic such as lidocaine, a drug that contracts theblood vessels such as epinephrine, and an intravenous (IV) saltsolution. The lidocaine in the mixture helps to numb the area during andafter surgery, and may be the only anesthesia needed for the procedure.The local anesthesia also contributes to the tumescence (swollen andfirm) of the target fat. The epinephrine in the solution helps reducethe loss of blood, the amount of bruising, and the amount of swellingfrom the surgery. The IV solution helps remove the fat more easily andit is suctioned out along with the fat. This type of liposuctiongenerally takes longer than other types. Less blood is also extractedalong with the fat over the wet and super-wet techniques.

The wet and super-wet techniques are similar to tumescent liposuction.The difference is that not as much fluid is used during the surgery—theamount of fluid injected is equal to the amount of fat to be removed.This technique takes less time; however, it often requires sedation withan IV or general anesthesia. Surgical blood loss is less for thesuper-wet technique than the wet technique but still more than thetumescent technique.

Power-assisted liposuction uses an electric variable speed motor togenerate a reciprocating motion and move the canula back and forth in away that mimics the movement made by a surgeon. It decreases the effortrequired and allows easier fat extraction.

Unfortunately, the nature of liposuction procedures preclude easy tissueisolation after initial harvest, especially on a large scale, becausethe volume and/or viscosity of the extracted liposuction effluent alsocontains unwanted components such as oil, blood and anesthetic solution.Currently, there are no standard techniques, methods, or devices thatexist for the simple, large scale isolation and refinement ofliposuction-harvested adipose tissue. Although a number of specializedcanulas, needles and methods for tissue harvest and preparation exist,these techniques are tedious and inefficient. Often, the harvested fatis introduced into a centrifuge further traumatizing the fat and addingmore steps to the process before the adipose tissue is re-injected backinto the patient. As a result, centrifuge-free processes have beendeveloped.

One example of a centrifuge-less system may be found in U.S. PatentApplication Publication No. US2006/0093527 to Buss. In general terms,the Buss harvesting and irrigation device is in the form of a syringehousing open on both ends and constructed to receive a removable filterchamber that slides within the housing. One end of the housing may becoupled to a conventional harvesting canula. The housing may form anairtight chamber for holding a vacuum pressure. The tubular filterchamber includes a porous surface and is supported within the housingand spaced apart from the interior wall of the housing so that fluid mayflow freely through the filter chamber and along a space between theouter filter chamber and the inner surface of the housing. The filter issized to contain a majority of fat cells aspirated into the filter froma lumen in the chamber. Fluids for washing the harvested fat cells maybe aspirated through the harvested material and out through the porousmaterial while holding the fat tissues within the filter chamber. Whilethis device does provide some advantages over prior solutions and may besuitable in some situations, there are a significant number ofcomponents that must manufactured and assembled to construct the deviceas well as a considerable amount of personal manipulation of the syringeplunger needed to perform the procedure. This includes several plungerretractions and depressions in order to fully pack fat into the syringehousing and also to draw in irrigation fluids to complete the process.This adds to the complexity of the overall training process as well.

Another example may be found in U.S. Patent Application Publication No.US2007/0225686 to Shippert. In general terms, the Shippert tissuetransplantation apparatus includes a collection vessel interconnected toa harvesting canula. The vessel defines a chamber in which a series oftissue collecting syringe bodies are coupled to a manifold also inconnection with the harvesting canula to provide multiple fillingstations. Each syringe body is perforated to retain fatty tissue in thesyringe body while allowing other smaller tissues to exit the syringebody. The chamber is also connected to a vacuum source to draw tissuefrom the canula into the manifold and on into one or more of the syringebodies. Under the same vacuum, some of the extraneous tissue is drawnout of the syringe bodies leaving fatty tissue behind.

Once the desired quantity of fatty tissue is collected, a syringe bodymay be disconnected from the manifold mount. However, an additionalsleeve is required to slip over the outer surface of the syringe body toform a sleeve or protective shell and seal before the syringe may beused. Otherwise, the fatty tissue would simply extrude out of theperforated syringe body as the plunger was depressed.

In another variation of the Shippert system, the harvested tissue isfirst directed into a tissue washing reservoir containing a fluid bath.However, the entry and exit ports are both provided on the lid of thereservoir and, as explained in Shippert, the washing reservoir must betipped over onto to its side so as to cover the exit port with washedtissue to allow the washed tissue to be suctioned from the tissuewashing reservoir into a manifold in communication with the perforatedsyringe bodies.

Yet another variation described in the Shippert publication reveals theuse of a collapsible filter bag within a collapsible collection bag heldwithin the collection canister to receive fatty tissue from theharvesting device. The filter may be used to separate out fatty tissueinto the interior of the collection bag from other fluids under suctionalso introduced into the collection bag. However, in order to access thefatty tissue in the filter bag, the bag must be removed from thecanister and the collection bag manipulated to decant unwanted fluids.If washing the tissue is desired, the collection bag is re-introducedinto the canister and a fluid additive is added while the bag ismassaged by hand to mix and rinse the fatty tissue. Transferring thecollected fatty tissue into a syringe involves forcing tissue through anupper port in the collection bag into a syringe body. While providing auseful multi-stage filling station, the number of steps using theseShippert devices results in a cumbersome harvesting and re-injectionprocess that may be improved upon.

While primarily used for tissue specimen collection, another solutionfor separating tissue may be found in U.S. Pat. No. 5,624,418 toShepard. In Shepard, a collection and separation device is disclosedthat includes a fluid collection container having a lid with afluid/tissue inlet port and a fluid outlet port that may be coupled to asuction source and a tissue harvesting device. The container alsoincludes a pair of ribs with a lower positioning ledge upon which a pairof tissue collection baskets or traps are positioned above the bottom ofthe container. While the bottom surface of the container is solidthroughout, each basket includes a plurality of fluid flow aperturesthrough which body fluids may pass through while retaining larger tissuespecimens in the basket. Fluid collected below the baskets is suctionedup through the fluid outlet port to drain the container, except for thetissue specimens remaining in the baskets. The lid may also be rotatedto aligned each basket with the entry port. However, there is no meansto access the collected tissue specimens with first removing the lidresulting in an increased exposure to the surrounding air. The basketsmay also be removed for further tissue analysis.

Despite these solutions to date, the need remains for an efficient,simple to use, low cost manufacture and assembly tissue collection andprocessing device that reduces the trauma to harvested tissue, improvesthe amount of useful tissue, and maintains a sterile processingenvironment.

SUMMARY

In accordance with the principles of the present invention, a preferredembodiment of a tissue refining device for collecting and processingtissue received from a harvesting device under suction from a vacuumsource may comprise a canister body including a vacuum port and anevacuation port operable to be placed in communication with the vacuumsource, a tissue harvesting port operable to be placed in communicationwith the harvesting device and to direct a quantity of tissue retrievedby the harvesting device into the canister body when suction is appliedto the vacuum port by the vacuum source, and a tissue retrieval port, avent or pressure equalization passage, and a separator element dividingthe canister body into an upper vacuum chamber in communication with thevacuum port and the tissue harvesting port and a lower vacuum chamber incommunication with the evacuation port, the separator element includingat least one aperture projecting through the separator element and adepression with a channel in communication with the tissue retrievalport.

In a related feature of the present invention, the evacuation portincludes an elongated tube extending from a canister body lid extendingthrough the upper vacuum chamber and through the separator element todispose an open lower end in the lower vacuum chamber from which fluidsmay be evacuated.

In another feature of the present invention, the vent passage is in theform of a vent tube concentrically arranged around an elongated draintube extending from the evacuation port.

Another feature of the present invention may be found in providing theseparator element with a tube mounting stub for coupling to the venttube.

Another aspect of the present invention is the introduction of a tissuecollection syringe and associated tubing coupled to the tissue retrievalport or an extension thereof to facilitate processed tissue collectionfor re-implantation into a patient site.

Other aspects of the present invention include the introduction of avacuum and fluid drain manifold coupled to vacuum and evacuation portsof the canister body with the fluid drain portion of the manifoldincluding a drain valve selectively operable to isolate the evacuationport.

In yet another aspect of the present invention, a plurality of aperturesof the separator elements are positioned at a fixed height within thecanister body and a lower end of the evacuation port is disposed inclose proximity to the aperture height.

A system for collecting and processing harvested tissue received from aharvesting device under suction using the afore-mentioned canister bodyplaced in series with a waste canister, vacuum source, and harvestingdevice is also disclosed herein.

A method for collecting and processing harvested tissue received from aharvesting device under suction for subsequent re-introduction into apatient is also disclosed herein.

Other aspects of the present invention will become apparent with furtherreference to the following drawings and specification.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an upper right perspective view of an exemplary embodiment ofa device for collecting and refining tissue received from a harvestingdevice in accordance with the principles of the present invention withthe device including a partial manifold assembly and being suspended bya holding tray and coupled to a tissue retrieval syringe;

FIG. 2 is a front elevation view of the tissue refining device of FIG.1, with the manifold removed, in enlarged scale;

FIG. 3 is a top plan view of the tissue refining device of FIG. 1 withthe manifold removed, in enlarged scale;

FIG. 4 is a left elevation view of the tissue refining device of FIG. 1,with a portion of the manifold coupled thereto and the switch in aclosed position, in enlarged scale;

FIG. 5 is a right elevation view of the tissue refining device of FIG.1, with a portion of the manifold coupled thereto and the switch in anopen position, in enlarged scale;

FIG. 6 is bottom view of the tissue refining device of FIG. 1, inenlarged scale;

FIG. 7 is a top plan view of the tissue refining device of FIG. 1, inenlarged scale, looking down into the canister body with the lidremoved;

FIG. 8 is a bottom view of the lid of the tissue refining device of FIG.1, in enlarged scale;

FIG. 9 is an enlarged cutaway view of the valve housing in FIG. 8,illustrating the vacuum port sealing valve and the valve in the openposition, with the housing shown in enlarged scale;

FIG. 10 is a similar view to FIG. 9 with the valve in a closed position;

FIG. 11 is a partial cutaway view of the tissue refining device of FIG.1 with the lid removed, in enlarged scale;

FIG. 12 is a similar view to FIG. 5 with a portion of the vacuummanifold attached and including a fluid bath and fatty tissue at anearly stage in the harvesting process;

FIG. 13 is a similar view to FIG. 12 further along in the separation andirrigation process;

FIG. 14 is a similar view to FIG. 13 further along in the separation andirrigation process;

FIG. 15 is a similar view to FIG. 14 with the tissue refining deviceconnected to a tissue retrieval syringe that is partially withdrawn andshows tissue collected in the syringe housing with the pinch clamp open;

FIG. 16A is a schematic diagram of a tissue harvesting, separating,irrigating, and retrieval system in accordance with the principles ofthe present invention and at an early stage in the harvesting process;

FIG. 16B is a similar view to FIG. 16A further along in the process withthe fluid bath partially evacuated;

FIG. 16C is a similar view to FIG. 16B further along in the process withthe irrigation process completed;

FIG. 16D is a similar view to FIG. 16C further along in the process withthe tissue being retrieved by the attached tissue collecting syringe;

FIG. 17 is a cross section of another exemplary embodiment of a canisterassembly for refining harvested tissue in accordance with the principlesof the present invention; and

FIG. 18 is a cross section of the area taken from circle 18 of FIG. 17depicting an alternative venting construction.

DETAILED DESCRIPTION

Referring now to FIGS. 1-7, an exemplary embodiment of a tissue refiningdevice, generally designated 20, and in accordance with the principlesof the present invention, is illustrated. Referring specifically now tothe views in FIGS. 1-5, in general terms, the tissue refining device 20includes a canister body 22 that includes a set of four ports, namely, avacuum port 24, a fluid evacuation port 26, a tissue harvesting port 28,and a tissue retrieval port 30. The vacuum and fluid evacuation portsmay be operatively coupled to one or more vacuum sources 32 (FIGS.16A-C) while the tissue harvesting port may be operatively coupled to aconventional harvesting device 55 (FIG. 16A) to direct a quantity oftissue 36 (FIGS. 12-15 and 16A-C) retrieved by the harvesting deviceinto the canister body when suction or a negative pressure is applied tothe vacuum port by the vacuum source. The tissue refining device alsoincludes a separator element 38 dividing the canister body into an uppervacuum chamber 40 in communication with the vacuum port and the tissueharvesting port and a lower vacuum chamber 42 in communication with thefluid evacuation port. To facilitate the separation process, theseparator element may include a plurality of fluid flow apertures 44projecting through the separator element and a depression 46 with achannel 48 in communication with the tissue retrieval port.

The tissue refining device 20, also referred to herein as the separationcanister, may also be used as part of a larger tissue harvesting,refining, and retrieval system, generally designated 50, as shown inFIGS. 16A-C or as part of a tissue retrieval subsystem, generallydesignated 53, as shown in FIGS. 15 and 16D. As will described in moredetail below, the separation canister 20, when operatively placed incommunication with other components such as the vacuum source 32 (FIGS.16A-C), a waste canister 52 (FIGS. 16A-C), a collection syringe 54(FIGS. 1, 15, and 16A-D), and a tissue harvesting device 55 (FIG. 16A)using associated conduits and tubing, may be used as part of a highvolume, sterile, closed environment system that facilitates theharvesting of aspirated, adipose tissue, separating such tissue fromother collected tumescent fluids, oils, blood, and anesthetics, andprocessing and treating the harvested fatty tissue with anti-bacterialsolutions and other additives resulting in a quantity of refined fattytissue for use in autologous adipose transplantation. Pre-loading of theseparation canister with a fluid bath 94 (FIGS. 12-14 and 16A-C) asdescribed below may also be used to further reduce the trauma to theharvested tissue and contribute to the refining process.

Referring now to FIGS. 1-2, 4-7 and 11, the canister body 22 includes agenerally cylindrically shaped sidewall 56 that tapers outwardly fromthe bottom to the top and that terminates in an upper rim 58 with anoutwardly projecting flange 59 surrounding an open topped region 60 thatpreferably faces upwardly when in use. The rim forms an attachmentsurface for a removable lid 62 described below. In this exemplaryembodiment, the canister body may have a capacity as little as 100 ml onup to 4 L but a 1.2 to 2.0 L canister capacity has been found to besuitable for most autologous adipose tissue re-injection procedures.However, this is not meant to be limiting in any manner and othersuitable smaller or larger capacities as dictated by the procedure willoccur to one skilled in the art.

The lower end of the sidewall 56 of the canister body 22 transitionsinto a shoulder 64 and on into a flat bottom section 66 parallel to thetop opening 60. Centrally located within the bottom section is locatedthe tissue retrieval port 30 from which the refined tissue 36, as forexample shown in FIGS. 15 and 16C, may be obtained. Alternatively, aport extender as described below may be inserted through the orificecreated by the tissue retrieval port.

A suitable rigid plastic, implosion-proof, suction canister formodifying in accordance with the principles of the present invention isavailable from Bemis Company under the Bemis Healthcare brand. Thecanister is preferably hydrophobic.

With continued reference to FIGS. 1-2 and 3-7, set within the canisterbody 22 is the separator element 38 that in this exemplary embodiment isin the shape of a funnel. The funnel includes funnel body 67 with anupwardly facing surface 68 and a downwardly facing surface 70, and acircular rim 72 abutting the interior surface 74 (FIGS. 2 and 4-5) ofthe canister sidewall 56. The funnel body includes an upwardly facingconcavity forming the depression 46 (FIGS. 7 and 11) with a centrallypositioned and downwardly projecting spout 76 (best viewed in FIGS. 1-2,4-5, and 12-15) that defines the channel 48 leading to and extendingpast the tissue retrieval port 30 outside the canister body 22.

In this exemplary embodiment, the funnel spout 76 projects through thetissue retrieval port 30 and extends beyond the base section 66 of thecanister body 22 thus effectively creating a port extender for thetissue retrieval port outside the canister body. The port extender 76may be conveniently coupled to a length of tubing as will be describedbelow. The port extender also terminates in a spout opening 77 that alsooperates as the tissue retrieval port by providing access to the topsurface 68 of the funnel and upper vacuum chamber 40 from beneath theseparation canister 20. It will be appreciated that the spout may alsoterminate at the tissue retrieval port or be recessed within thecanister body 22 as long as there is an orifice on the canister bodyleading to the upper surface 68 of the separator element 38.

With reference now to FIGS. 1-2, 4-5, and 11-15, the funnel 38 spans thediameter of the canister body 22 and effectively forms a perforated sealbetween the upper and lower vacuum chambers 40 and 42, respectively,when viewed in connection with the fluid flow apertures 44 discussedbelow. The funnel may be fixed in place within the canister body and byattaching a locking ring 79 (FIG. 6) having a set of teeth or grippingelements to capture the exterior surface 81 (FIGS. 4-5 and 7) of theportion of the spout extending outside the canister body to prevent thefunnel from sliding relative to the canister body. In this exemplaryembodiment, the upper edge 78 of the funnel is set at a height about the300 ml mark on a 1.2 L canister or about ¼ the height of the canisteroff the bottom wall while the lower point 80 of the funnel body 67leading to the spout 76 resides at or near the interior surface of thebase section 66. A pressure seal 82 (FIG. 2) encircling the portion ofthe separator 38 where the funnel body 67 meets the spout 76 may be usedto provide a better seal where the funnel interfaces with the tissueretrieval port 30.

As best shown in FIGS. 1-2, 4-7 and 12-15, concentrically arrangedaround the central channel 48 is a singular ring of spaced apart fluidflow apertures 44 (also referred to as fenestrations or perforations)that bore completely through the funnel body to allow fluids such asoils, free lipids, tumescent fluids, non-fatty tissues, blood,anesthetic fluids, and saline gathered during the harvesting process orintroduced into the canister body 22 to drain from the upper vacuumchamber to the lower vacuum chamber while restricting the passage ofadipose tissue. A preferable aperture size of 1.0 mm has been determinedto be suitable for the desired flow rate while avoiding clogging issuesbut other suitable sizes, including, but not limited to an aperture sizerange of 0.2 mm to 2.0 mm, depending on the tissue being collected,quantity desired, and desired pass through rate without undue cloggingwill occur to one of ordinary skill in the art. The ring of apertures isset at a fixed height within the canister body and, in this exemplaryembodiment, the apertures appear at about the 100 ml mark in a 1.2 Lcanister and above the top edge of the spout 76 or about half down inthe depression 46.

In addition, while a single ring of fixed height apertures 44 is shownin this example, additional rings may be used or the apertures mayappear at varying heights throughout the funnel body. Depending on thevacuum strength introduced by the vacuum source 32 (FIGS. 16A-C) in thelower vacuum chamber 42 some of the fatty tissue may pass through orinto the apertures. However, clogging is generally avoided since thefatty tissue tends to float in the fluid bath 94 (FIGS. 12-14 and 16A-C)and such fatty tissue only settles onto the funnel once all otherrinsing and bilge fluids has been evacuated through the funnel aperturesinto the lower vacuum chamber 42. While the funnel body 67 is preferablyconstructed of a rigid material, other suitable materials will occur toone of ordinary skill in the art and the ring of apertures may beprovided by a mesh region instead of through bores or a combinationthereof. In this exemplary embodiment, there are twenty apertures orfenestrations, however, this is not meant to be limiting in any mannerand other suitable numbers of apertures will occur to one of ordinaryskill as well. For example, as few as six apertures has been found to besuitable for the washing and straining process. Instead of apertures,slots may be used as well.

Referring now to FIGS. 5 and 7, the funnel body 67 also includes apass-through orifice 84 that is enlarged relative to the apertures 44 inthis exemplary embodiment. The pass-through orifice facilitates theextension of a hollow drain fluid evacuation tube 86 from the evacuationport 26 through the funnel body to dispose the lower end 88 of theevacuation tube within the lower vacuum chamber 42 or bilge area. Thiseffectively places the evacuation port 26 in communication with thelower vacuum chamber. The fluid evacuation tube effectively provides aport extender for the fluid evacuation port 26 on the lid 62 asdescribed next.

Turning now to FIGS. 1, 3-5, 8, and 12-15, covering the open top 60 ofthe canister body 22 is a removable, self-sealing lid 62. Thesubstantially flat lid includes a complementary flange 90 for matingwith the rim flange 59 to seal off the upper portion of the upper vacuumchamber 40 and further provides access to the vacuum port 24, fluidevacuation port 26, and tissue harvesting port 28 (also referred to asthe patient port) as well as an auxiliary enlarged fill port 92 foradding a sterile saline solution or other desired fluid bath 94 (FIGS.12-14) into the upper vacuum chamber.

As shown in FIG. 3, each port 24, 26, 28, and 92 may have a closure cap96, 98, 100, and 102, respectively, that is also tethered to the lid 62.The caps may be snapped on, screwed on, pressed on, or otherwisesuitably engaged with their respective ports. Other suitable closureswill occur to one of ordinary skill in the art. The upper surface 104(FIG. 3) of the lid is substantially flat throughout with each portincluding an upwardly projecting cylindrical spout or tube to serve as amounting surface for the corresponding cap. The vacuum port 24, thetissue harvesting port 28, and auxiliary fill port 92 each provideaccess directly into the upper vacuum chamber 40. Extending downwardlyfrom the fluid evacuation port 26 is the fluid evacuation tube 86 thateffectively extends the lower opening of the evacuation port to a lowerlocation 106 in the lower vacuum chamber 42. The top end of theevacuation tube 107 (FIG. 11) may be slip fit onto or into theevacuation port or otherwise suitably secured to the port. Theevacuation port 26 and tube 86 may be used to evacuate or draintumescent fluids, oils, bloods, anesthetics, and other unwanted bilgefluids from the lower vacuum chamber under suction from the vacuumsource 32 (FIGS. 16A-C).

Referring now to FIGS. 2 and 8-10, the underside 108 of the lid 62 andpositioned beneath the vacuum port is an overflow shutoff valve 110. Theoverflow shutoff valve includes a cylindrical valve housing 112 with aflange 114 that may be snap fit or screwed into a complementaryretention flange 116 projecting from the underside of the lid. Thebottom of the housing includes a set of three spokes 118 a, 118 b, and118 c projecting from a central hub 120 (FIG. 8) to the outer wall ofthe housing and forming three roughly pie-shaped openings 119 a, 119 b,and 119 c. When viewed in cross-section (FIGS. 9-10), the hub includes acentral post 122 projecting up into the valve housing that a float valve124 may slide up and down on. The float valve includes an enlarged base126 and a central tube 128 that fits loosely over the post 122 and iscapped by a flexible seal 130.

As the float valve 124 rises in response to rising fluid within theupper vacuum chamber 40, the flexible seal 130 may be brought intocontact with a gasket 132 covering an enlarged chamber 134 set justbeneath the interior of the vacuum port 24 spout. A central opening 135in the gasket may be closed off by the flexible seal when the floatvalve encounters rising fluid levels within the upper vacuum chamber 40that enter the valve housing 112 through the openings 119 a-c betweenthe spokes 118 a-c in the base of the valve housing as will be explainedfurther below. The float valve acts as a shut off feature to seal offthe vacuum port should the fluid levels get too high within the canisterbody 22. A thin porous paper film 136 may be interposed between thegasket and the entry to the vacuum port to both control the suctionforce in the upper vacuum chamber and to prevent debris from beingsucked into the vacuum port. This film or fibrous wafer contributes tothe creation of a vacuum differential between the upper and lower vacuumchambers 40 and 42, respectively during the fluid evacuation process aswill be described below. Also, a semi-circular splash guard 138partially surrounds the entry to the tissue harvesting port 28 on theinside of the lid 62.

Referring to FIGS. 1, 4-5, and 12-15, a vacuum manifold, generallydesignated 140, may be operatively coupled to the vacuum port 24 andfluid evacuation port 26 for applying a suction force at each port. Inthis exemplary embodiment, the manifold includes a first branch 142,constructed of ⅜ inch tubing, with one end coupled to the centrallylocated vacuum port 24 and a second branch 144, constructed of ⅝ inchtubing, with one end coupled to an upper extension of a cross-piece tube146. The upper ends of both branches flow into a central extension 148with a free end 150 that may be operatively coupled to the vacuum source32 (FIGS. 16A-C). The opposing vertical end 152 of the cross-shaped tubemay be slipped over or plugged inside the evacuation port 26 to completethe path from the free end of the manifold to the evacuation port. Thetransverse projecting section 154 of the cross-shaped tube includes amanual drain valve 156 that may be selectively reciprocated from a firstposition (FIG. 4) blocking the path to the evacuation port 26 to asecond position (FIG. 5) clearing the path to the evacuation port 26.Alternatively, a Y-shaped adapter and short segments of tubing may beused to form the manifold.

Turning now to FIGS. 16A-C, a schematic block diagram of the wastecanister 52 is shown. A conventional waste canister with a lid 158having a downstream vacuum port 160 that may be coupled to the vacuumsource 32 via a length of tubing 161 and an upstream vacuum port 162that may be coupled to the free end 150 of the manifold 140 via a lengthof tubing 164. In this exemplary embodiment, the capacity of the wastecanister is preferably greater than or equal the capacity of theseparation canister 20. A suitable rigid plastic, implosion-proof,suction waste canister is available from the Bemis Company under theBemis Healthcare brand. The waste canister is also preferablyhydrophobic.

Referring now to FIGS. 1, 15, and 16A-D, the adipose tissue collectionsyringe 54 may be a conventional syringe with a hollow housing 166defining a collection chamber 167 having an entry channel 168 on one endthat may attach to a canula (not shown) for enabling re-injection of thecollected tissue into a patient site or another syringe body. A plunger170 may be inserted into the enlarged opposing end 169 of the housingand may be reciprocally manipulated within the housing. A conventional60 cc Toomey syringe has been found to be suitable in this exemplaryembodiment but this is not meant to limiting in any manner and othersuitable syringe capacities as driven by the procedure and quantity oftissue required will occur to one of ordinary skill in the art.

The syringe 54 may be connected to the lower end of the funnel spout 76(FIGS. 1-2, 4-5, 12-15, and 16A-D) that extends out the tissue retrievalport 30 using an adipose tissue collection tube 172 having a syringeside end 173 and an opposing spout side end 175. A pinch clamp 174 maybe used to slip over the tubing to selectively open and close off thetubing path. When the pinch clamp is open, the syringe collectionchamber 167 is placed in communication with the upwardly facing surface68 of the funnel 38 via the tissue collection tube 172 and channel 48.

Referring to FIGS. 16A-C, the vacuum source 32 (also referred to as avacuum pump, suction pump, or aspirator) is a vacuum device having aprimary vacuum port 176 that may be operatively connected to thedownstream port 160 of the waste canister via a suitable length oftubing or conduit 178. A conventional vacuum source, available from MDResource in Danville, Calif., and having a typical operating range from1-29 inches Hg has been found to be suitable to both harvest fattytissue through the conventional canula 55 (FIG. 16A) and withdraw fluidbath and bilge fluid 94 (FIGS. 12-14) from the lower vacuum chamber 42of the canister body 22 into the waste canister 52. In this exemplaryembodiment, it is preferred that the vacuum source be selectivelyoperable to induce a pressure vacuum in a controlled manner to a rangeof 15-20 inches Hg to perform the procedure but other suitable pressurereadings will occur to one of ordinary skill in the art.

Referring now to FIG. 1, as it is preferred to hold the separationcanister 20 in an upright orientation during the procedure, a stainlesssteel holding tray 51 may be provided having a cutout 180 in a holdingplatform 181 sized to receive and suspend the bottom surface 66 of thecanister body 22 up off a lower support surface (not shown) with a pairof folding legs 182. It will be appreciated that the legs of the tray,when extended, are of a sufficient length to suspend the canister 20 offan underlying support surface. Alternatively, the canister body mayinclude a hanger (like for a paint bucket) and be suspended from ahanger tree during use and/or storage.

The harvesting device, generally designated 55, as schematicallyrepresented in FIG. 16A, is a conventional harvesting device having aselected canula 184 and a port 186 for coupling to a vacuum hose 188that may in turn be connected to the tissue harvesting port 28 fordirecting tissue from the patient site and gathered in the canula to thetissue harvesting port and on into the upper vacuum chamber 40 of thecanister body 22 during the harvesting process as will be explainedbelow. A suitable harvesting canula for liposuction techniques andcoupling to the separation canister 20 is also available from MDResource, however, the choice of device and canula size are left up tothe surgeon as determined by the procedure.

All tubing and conduits described herein are preferably constructed fromrigid or flexible silicone or PVC plastic tubing capable of withstandingthe negative pressures introduced into the system without collapsing.The separation canister 20, associated tubing and conduits 164, 172,178, 188, the evacuation tube 86, and separator element 38, and manifold140 are also preferably constructed of a transparent or translucentmaterial to facilitate observation of the process by the surgeon. Therigid plastics of the canisters, funnel, lid and rigid plastic tubes maybe formed using conventional blow or injection molding techniques,extrusion, or other suitable plastic shaping and forming techniques. Astyrene or polycarbonate based plastic material has been found suitable.The vacuum source 32, waste canister 52, collection syringe 54, andharvesting device 55 are conventional off the shelf components readilyavailable in the liposuction industry. The stainless steel holding tray51 may be stamped, pressed, or bent using conventional metal shapingtechniques.

To facilitate the understanding of the operation of the tissue refiningdevice 20 and associated system 50, turn now to FIGS. 1, 12-15, and16A-D. The main components 20, 32, 51, 52, 54, and 55 of the system 50and subsystem 53 for harvesting, refining, and collecting adipose tissuefor autologous tissue transplantation may be operatively assembledtogether in series using the corresponding connective tubing or conduits178, 164, and 188. In this exemplary process, refining refers toperforming one or more of the collection, separation, irrigation, andtreatment processes on the harvested fatty tissue prior tore-introduction into the patient.

Within this process description, it is assumed that the respectivebranches, 142 and 144 of the manifold 140 are already connected to thecorresponding vacuum port 24 and evacuation port 26 on the lid 62 andhas one free end 150 as shown in FIGS. 12-15. The drain valve 156 isalso interposed between the evacuation port 26 and the second branch 144of the manifold and in the closed position as shown in FIG. 4. It isfurther assumed that the separator 38 is fixed in place within thecanister body 22 to separate the upper vacuum chamber 40 from the lowervacuum chamber 42 and the funnel spout 76 extends out through the tissueharvesting port 30 on the base section 66 of the canister body as shownin FIGS. 1-2, 4-5, 12-15, and 16A-D. The lid 158 of the waste canister52 is also understood to be in place with the downstream vacuum port 160and upstream vacuum port 162 uncapped or otherwise exposed. Theevacuation tube 86 is also coupled to the evacuation port 26 of the lid62 as shown in FIG. 5 for example.

As shown in FIG. 1, a surgeon (or surgeon's assistant) may place theseparation canister 20 in the cutout 180 of the holding tray 51 havingits legs 118 a, 118 b extended to hold the canister body 22 in anupright configuration with the upper vacuum chamber 40 verticallyaligned with, having a common central axis, and disposed above the lowervacuum chamber 42. The upper flange 59 of the canister body 22 restingon the tray surface 181 ensures the separation canister does not passthrough the cutout and instead remains with its base section 66suspended off a lower support surface.

Referring now to FIGS. 2-5 and 12-15, the lid 62 may be placed on thecanister body 22 by the surgeon to seal off the top open end 60 (FIG.11) of the canister body and dispose the lower end 88 of the fluidevacuation tube 86 through the orifice 84 in the funnel body 67 andwithin the lower vacuum chamber 42 so that the lowermost opening 106 isdisposed above, at the same height, or beneath the height of theapertures (aperture line) and above the base section 66 of the canisterbody 22. Various evacuation tube heights, for example, are shown inFIGS. 2, 4-5, and 12-15. The variation of the height of the lower end ofthe evacuation tube will vary the point at which a vacuum break formsand the drain fluid is no longer evacuated from the lower vacuum chamber42 or bilge area. The caps 96, 98, 100, and 102 may be removed fromtheir respective ports 24, 26, 28, and 92 by the surgeon. The drainvalve 156 may be slid to the closed position (position A in FIG. 17A andas shown in FIG. 4), if not already in such position to isolate theevacuation port 26 from the vacuum source 32 when the vacuum source orsuction pump is later activated.

Referring to FIGS. 1, 15, and 16A, the canister-side end 175 of a fatcollection tube 172 may be coupled to the funnel spout 76 of thecanister body 22 by the surgeon. The pinch clamp 174 may be slid overthe free end 173 of the fat collection tube and pinched to close off thefat collection tube as in FIGS. 1 and 16A-C. The syringe-side end 173 ofthe fat collection tube may then be connected to the port 168 of theToomey fat collection syringe 54. The places the fat collection syringein communication with the upper vacuum chamber 40 of the canister body22, although the path is closed by the pinch at this point in theprocess.

Referring to FIGS. 16A-C, the waste canister 52 may also be placed on aflat surface or side by side with the separation canister in a similarholding tray 51. The free end 150 of the manifold may be operativelyconnected to the upstream vacuum port 162 of the waste canister 52 usingthe conduit 164. This places the separation canister 22 in series withthe waste canister 52. The downstream vacuum port 160 of the wastecanister 52 may be connected to the vacuum source port 176 of the vacuumpump 32 with another length of vacuum tubing 178. If necessary, thevacuum pump is plugged into a power source but not yet activated.

Still referring to FIGS. 16A-C, a free end of a length of fat harvestingtubing 188 is coupled to the tissue harvesting port 28 (patient sideport) on top of the lid 62. The opposing free end of the fat harvestingtubing is coupled to a conventional fat harvesting device 55 having acanula attachment 184 for retrieving fatty tissue from the patient site.With the tissue harvesting device 55 now in place, it will beappreciated that the vacuum source 32, waste canister 52, separationcanister 20, and tissue harvesting device 55 are connected in series asillustrated in FIG. 16A to begin the process.

The fill port cap 102 (FIGS. 1 and 3) of the enlarged fill port 92 onthe lid 62 may be removed by the surgeon and an optional fluid bath 94,such as sterile saline or Ringer's lactate solution, may be poured intothe canister to fill the canister up to a desired fill line above theupper edge 72 of the funnel. In this exemplary process, the fluid bath94 fills the lower vacuum chamber 42 beneath the separator 38 and fillsup a portion of the upper vacuum chamber 40 so that the upper fluid line95 is above the funnel rim 72. This pre-loads the canister with about400 ml or more of sterile fluid bath. It is preferable to ensure theratio of fluid bath to harvested fat is in favor of the fluid bathallowing the fatty tissue to float initiating the separation process.Other treatments such as antibiotics and/or sterile tissue washing andseparation fluids may also be introduced at this time or later on in theprocess through the fill port 92 as the surgeon determines. Suchrefining fluids may be introduced for a period of time or incrementallyas the surgeon sees fit to wash, separate, and treat the harvestedtissue 36. The fill port cap 102 is then placed back on the fill port92.

At this point, the fill port 92 is capped, the vacuum port 24 andevacuation port 26 are in communication with the vacuum source 32,although the evacuation port is isolated due to the closure of the drainvalve 156, the tissue harvesting port 28 is connected to the harvestingdevice 55, and the tissue retrieval port 30 is coupled to the syringe 54that is also closed off by the pinch clamp 174 as shown in FIG. 16A.This arrangement presents a pathway from the harvesting device 55 intothe upper vacuum chamber 40 through the harvesting tube 188 and patientport 28. There is also a path from the tissue harvesting port 28 to thevacuum port 24 through the upper vacuum chamber 40 of the separationcanister 20. There is also a clear path from the primary vacuum port 176on the vacuum source 32 to the downstream vacuum port 160 of the wastecanister 52 via the vacuum tubing 178. The vacuum path continues throughthe upstream vacuum port 162 of the waste canister 52 through the vacuumtube 164 to the manifold 140 and onto the vacuum port 24 on the lid 62of the separation canister 20.

Referring now to FIGS. 1, 12-15, and 16A-C, the vacuum source 32 may beturned on by the surgeon and the pump allowed to build to a suitablevacuum (negative) pressure to perform the fatty tissue 36 harvestingprocess with the harvesting device 55 using conventional harvestingtechniques. The overflow shutoff valve 110 is not responsive to thesuction force initiated by the activation of the vacuum pump 32 and thevacuum port 24 remains open. With the vacuum source activated, a vacuumpressure relative to the ambient pressure will be generated andmaintained in the upper vacuum chamber 40. A vacuum pressure range of15-20 inches Hg has been found suitable to maintain a sufficient suctionforce in the upper vacuum chamber 40 to provide sufficient suction tothe harvesting device 55 for aspirating fatty tissue 36 from the patientand into the separation canister 20. It will be appreciated that thefluid bath 94 will not exit the upper vacuum chamber with the vacuumseal closed. In addition, no fluid is evacuated through the evacuationtube 86 as the drain valve 156 has isolated the evacuation port 26 fromthe vacuum source 32 at this point.

Using conventional liposuction techniques, the canula 184 of theharvesting device 55 may be inserted into a patient site and a quantityof fatty tissue 36 harvested under vacuum. The fatty tissue will travelthrough the fat harvesting tube 188 and is directed through the tissueharvesting port 28 to fall into the fluid bath 94 in the upper vacuumchamber 40 of the separation canister 20 as shown in FIGS. 12 and 16A.As commonly occurs during the adipose tissue aspiration process, otherfluids and tissues such as blood, anesthetic, collagen strands,infiltrated tumescent fluids, oils, and other non-fatty tissues andfluids may be aspirated along with the fatty tissue. It will beappreciated that the process of separating the fatty tissue from otherfluids and non-fatty tissue and fluids begins immediately. While thefatty tissue may initially sink as it is introduced into the fluid bath,the more buoyant fatty tissue tends to rise within the fluid bath andwill ultimately float at or near the upper water line 95 of the fluidbath. It will be appreciated that pre-loading the canister body 22 witha fluid bath 94 also cushions the entry of the fatty tissue into thecanister thus reducing the trauma to the tissue as well as irrigatingthe tissue. As the fluid bath 94 mixes with the aspirated tissues, itbecomes bilge fluid that will later be evacuated further on in theprocedure.

Once enough fatty tissue 36 is collected as determined by the surgeon orsurgeon's assistant to complete the transplantation or re-injectionprocedure, the vacuum source 32 may be left on at the same pressurereading or reduced at this point. As a back up, the overflow shut offvalve 110 will seal off the vacuum port 24 should the fluid level 95within the upper vacuum chamber rise sufficiently and enter the openings119 a-c between the spokes 118 a-c of the shutoff valve housing 112 toforce the seal 130 on the top of the float valve 124 to close off thecentral opening 135 of the gasket 132. Should this occur, the vacuumport 24 will be sealed off and no more fluids will enter the canisterbody 22 through the harvesting port 28. However, it is preferable toturn off the vacuum source while the fatty tissue sits in the fluid bath94 for a short interval as discussed below. The fat harvesting tube 188and associated harvesting device 55 may also be disconnected from thelid 62 by the surgeon by removing the harvesting device-side end of thetissue harvesting tube from the tissue harvesting port 28. Theharvesting port may be closed temporarily but should preferably remainopen during the fluid evacuation process described below. Alternatively,the fat harvesting device 55 may be removed from the harvestingdevice-side end of the fat harvesting tube and the fat harvesting tubemay be closed off using a pinch clamp similar to the pinch clamp 174 onthe fat collection tube 172 and then later opened up for the fluidevacuation process. Another alternative would be to introduce anopen/close valve into the fat harvesting port 28 or harvesting tube 188for similar operation to the pinch clamp.

As shown in FIGS. 12-13 and 16B, at this point, the fatty tissue 36 maybe allowed to sit in the fluid bath 94 for several additional minutes,if desired, further allowing the fatty tissue to separate from otherharvested fluids and tissues due to its buoyancy to further facilitatethe separation process. While shown as slightly settled in the fluidbath 94 in the figures, the fatty tissue 36 generally floats at or nearthe top surface 95 of the fluid bath.

Assuming the vacuum source 32 was turned off in the prior step, once adesired degree of buoyancy separation takes place, the surgeon may thenturn the vacuum source 32 back on and bring the pressure reading back toa range of 15-20 inches Hg suction force reading, although a lowersuitable suction pressure may be used depending on the evacuation speeddesired. The surgeon may uncap the harvest port 28, if necessary, andalso slide the reciprocal drain valve 156 to the open position B (FIG.16B and as shown in FIG. 5) thus placing the lower vacuum chamber 42 indirect communication with the vacuum source 32 via the waste canister 52through the associated tubing 164 and 178. It will be appreciated thatthe drain valve may be opened before the vacuum source activation. Ifthe vacuum source was left running during the prior step, the operatingsetting for the fluid evacuation process may be brought back to a rangeof 15-20 inches Hg, if not already at that setting. The opening of thedrain valve also switches the primary vacuum force from the upper vacuumchamber 40 to the lower vacuum chamber 42.

With the vacuum source 32 operating at the desired pressure reading andthe drain valve 156 open, the irrigation and separation processescontinue. As the bilge fluid 94 (fluid bath and other non-fatty tissue)passes from the upper vacuum chamber 40 through the apertures 44 in thefunnel 38, the bilge fluid accumulates in the bilge area or lower vacuumchamber 42. A pressure differential, created by the fibrous wafer 136between the vacuum port 24 and the upper vacuum chamber 40, may occurbetween the upper and lower vacuum chambers 40 and 42, respectively, infavor of the lower vacuum chamber as some suction is applied to bothchambers by the common vacuum source 32. Applying some vacuum to theupper vacuum chamber allows for better control of the fluid evacuationprocess. Even with a relatively weak pressure differential, the pressuredifferential does assist in controlling a steady rate of evacuation.This approach allows the fluid bath 94 to be drawn from the upper vacuumchamber 40 through the apertures 44 in the funnel 38 and into the lowervacuum chamber. As the fatty tissue 36 typically floats on top of thefluid bath after it has been dunked and rinsed, the fluid bath and othernon-fatty tissue may be separated from the fatty tissue and evacuatedthrough the evacuation tube 86. A vacuum setting of 15-20 inches Hg hasfound to be provide a suitable evacuation rate of bilge fluid 94 fromthe lower vacuum chamber 42 through the open end 106 of the evacuationtube 86, out through the evacuation port 26 and vacuum tubing 164leading to the upstream vacuum port 162 of the waste canister 52.

As shown in FIGS. 12-15 and 16A-C, the fatty tissue 36 is also preventedfrom entering the lower vacuum chamber 42 due to the size of theperforations 44 in the funnel 38. In addition, as the fatty tissue tendsto float on the fluid bath 94, it is unlikely to block the apertures 44.Bilge fluid 94, including both saline bath and non-fatty tissues andother fluids collected from the patient during the harvesting procedure,continues to be collected beneath the funnel in the lower vacuum chamberand evacuated under suction.

The bilge fluid 94 is then drawn out through the lower opening 106 ofthe evacuation tube 86 past the drain valve 156 and through the manifold140 and on into the waste canister 52 via the vacuum tubing 164 as shownin FIGS. 16B-C. The weight of the bilge fluid ensures it is depositedinto the waste canister and not through the downstream vacuum port 160in the lid 158 of the waste canister and into the vacuum source 32connected via vacuum tubing 178. A filter in the suction path to thevacuum pump 32 may also be used to prevent debris from entering thevacuum source.

As shown progressively in FIGS. 12-14 and FIGS. 16A-C, the fluid level95 in the separation canister 20 continues to drop as more and morebilge fluid is evacuated. Once the fluid level drops beneath the loweropening 106 of the evacuation tube 86, a vacuum break is formed and nomore fluid is withdrawn from the lower vacuum chamber. It will beappreciated that this feature provides an auto shut off of the bilgewater evacuation process and the surgeon may walk away during thisdraining part of the procedure, if necessary. The depth of the lowermostopening 106 of the evacuation tube 86 determines the shut off point. Thefurther the evacuation tube extends into the lower vacuum chamber 42,the more bilge fluid 94 will be evacuated. In this exemplary embodiment,it is preferred to locate the bottom edge 106 of the evacuation tube 86at a position slightly higher than the horizontal aperture line formedby the apertures 44 relative to the base section 66 of the canister body22. However, it will be appreciated that the lower end of the evacuationtube may be placed at the same height or lower height than the apertureline.

At this point, as shown in FIGS. 14-15 and 16C, almost all of the fluidbath 94 in the upper vacuum chamber 40 has been evacuated into the wastecanister 52 except for some residual fluid that may remain in the lowerregion of the depression 46 of the funnel 38 beneath the apertures 44 orbelow the evacuation tube 86 in the lower vacuum chamber 42. The fattytissue 36, as it settles into the depression 46, may also cause some ofthe residual fluid to spill out the apertures and into the lower vacuumchamber separating more of the bilge fluid from the fatty tissue. Itwill be appreciated that the concave upper surface 68 of the separatorelement 38 concentrates the fatty tissue 36 about the channel 48 leadingto the retrieval port 30 and out the spout opening 77 without anyfurther handling as the fluid bath 94 is evacuated from the upper andlower vacuum chambers 40 and 42, respectively.

Once the bilge water 94 is substantially removed, it will be appreciatedthat the remaining fatty tissue that settles onto the funnel 38 hasalready been rinsed by and separated from the saline bath due tobuoyancy, then rinsed and separated from the fluid bath 94, otheradditives, and the non-fatty fluids and tissues under a gentle vacuum,all within a sterile closed environment of the separation canister 20.The remaining refined fatty tissue is heavily concentrated and ready forre-introduction into the patient. The refined fat remains trapped on thetop surface 68 of the funnel 38 within the canister body 22. After theinitial washing and separation steps, treatment additives such asantibiotics may be added through the fill port 96 to the fatty tissue36. The washing process may be repeated one or more times as well tofurther refine the fatty tissue 36.

The vacuum source 32 may then be turned off to release the vacuum in thecanister body 22. Also, if desired, the drain valve 156 may be slid tothe closed position (FIG. 5) to again isolate the evacuation port 26from the vacuum source.

Referring now to FIGS. 15 and 16D, the fat collection tube 172 coupledto the funnel spout 76 may contain some remaining bilge fluid 94. Thesurgeon may open the pinch clamp 174 on the tube 172 and draw back thesyringe plunger 170 to draw out any remaining bilge fluid collected inthe length of the fat collection tube. The syringe 54 may be decoupledfrom the syringe-side end 173 of the tube and the excess bilge fluidexpelled into the waste canister 52 by depressing the plunger 170.

The plunger 170 of the fat collection syringe 54 may then be pushed backinto the syringe chamber 167 and the syringe may be coupled back to thefree end 173 of the fat collection tube 172 attached to the funnel port76. This places the syringe in direct communication with fatty tissue 36collected on top of the funnel 38.

The plunger 170 of the syringe 54 may then be drawn back to draw fattytissue 36 from the upwardly facing funnel surface 68 into the syringecollection chamber 167 as shown in FIGS. 15 and 16D. It will beappreciated that the collected fatty tissue 190 (FIG. 15) was obtainedwithout entering or opening the canister body 22. The gently slopingsidewalls of the funnel body 67 and the channel 48 also cooperate toprovide a fat retrieval chute directing refined fatty tissue to thecollection syringe 54 via the collection tube 172. If more than onesyringe is needed, the primary syringe may be uncoupled and additionalsyringes as needed may be coupled to the tubing end 173 and thecollection process repeated to load one or more syringes with irrigated,separated fatty tissue for re-injection.

The syringe 54, now loaded with fatty tissue 36, may be coupled to adesired canula (not shown) by the surgeon, and the fatty tissuere-injected into the patient site using conventional autologous fattytissue re-injection techniques. The syringe 54 may also load a smallersyringe with the refined fatty tissue for lower volume re-injections ifelected by the surgeon.

Any remaining fatty tissue 36 in the separation canister 20 may bestored for future use. The lid ports 24, 26, 28, and 92 may bedisconnected and capped off with their corresponding caps 96, 98, 100,and 102. Likewise, the funnel port 76 may be disconnected and capped offusing a similar cap or detachable cap. The canister may be stored asnecessary. Otherwise, the separation canister 20 along with itsseparator 38, fluid evacuation manifold 140, and evacuation tube 86 maybe discarded properly.

It will be appreciated that the foregoing separation canister 20 andrelated system. 50 and subsystem 53 and method as described hereincooperate to minimize the number of steps required to harvest, refine,and collect the fatty tissue prior to re-introduction into the patientsite. In addition, trauma to the tissue, commonly caused by the use of acentrifuge, rougher manipulation of the tissue and tissue container ascommonly occurs when directing the tissue against a solid surface, andextending the time of the tissue outside the patient is significantlyreduced using the components and methods described herein, all whilemaintaining a sterile environment As a result, a higher percentage ofviable adipose tissue is made available for transfer whilesimultaneously reducing the amount of cellular debris that may otherwisecommonly re-introduced into the patient along with the fatty tissue. Thetransparent nature of the separation canister also facilitates a simplevisual method for checking the tissue as well. The separation canisteralso advantageously may easily be integrated with conventional off theshelf waste canisters, vacuum sources, syringes, and harvesting devices.

As explained above, the variation of the height of the lower end of theevacuation tube 86 (in FIGS. 2, 4-5, and 12-15 for example) will varythe point at which a vacuum break forms and the drain fluid is no longerevacuated from the lower vacuum chamber 42 or bilge area. However, ithas been noted that once the vacuum break is created, the vacuum sourcewill continue to create a low pressure environment in the lower vacuumchamber. This may create an undesired effect on the fatty tissue 36 thathas settled onto separator element 38 and blocks the apertures 44 as inFIG. 14. As the fatty tissue covers the apertures and the residual fluiddrains into the lower vacuum chamber, the vacuum pressure in the lowervacuum chamber tends to pull on the fatty tissue attempting to draw thetissue through the apertures. While the more viscous fatty tissuegenerally resists being pulled through the openings 44 in the funnel,the added strain on the tissue from the suction forces underneath thefunnel may unnecessarily damage or traumatize the fatty tissue. Thisissue impacting the health of the fatty tissue may occur both prior tothe vacuum break and after the vacuum break once the fluid level dropsbelow the apertures and the fatty tissue is exposed to the apertures. Itmay also occur whether or not the tissue retrieval port is open orclosed during the draining process as the pressure in the lower chamberremains lower than the upper chamber. If the vacuum level is strongenough, some of the fatty tissue may even be pulled through theapertures and into the bilge area 42.

In addition, during the fluid evacuation process, a pressuredifferential, created by the fibrous wafer 136 between the vacuum port24 and the upper vacuum chamber 40, may occur between the upper andlower vacuum chambers 40 and 42, respectively, in favor of the lowervacuum chamber as some suction is applied to both chambers by the commonvacuum source 32. While applying some vacuum to the upper vacuum chambermay allow for better control of the fluid evacuation process, even witha relatively weak pressure differential, the pressure differential mayalso contribute to sputtering and spitting of the evacuation tube as airmixes with the fluid being withdrawn. It has also been found that theusing the two-position switch valve 156 to regulate the vacuum pressureby leaving it slightly open may contribute to some sputtering andspitting as well and agitating the draining fluids and causing irregulardrain flow rates. The vacuum break, switch valve, and overflow shutoffvalve components of the above-described embodiment may contribute toless than an ideal tissue refining system in certain instances. Thus,although the above-described embodiment has been found to be suitablefor many tissue refining scenarios, in some cases it is preferred topreserve as much fatty tissue on the separator element 38 for subsequentcollection in the least distressed state as possible. Consequently, asystem that results in less trauma to the fatty tissue while yielding ahigher percentage of viable adipose tissue by more thoroughly reducingthe amount of cellular debris that may otherwise commonly re-introducedinto the patient along with the fatty tissue is highly desirable.

Turning now to FIG. 17, a cross-section of another exemplary embodimentof a tissue refining canister assembly, generally designated 220, foruse with the tissue refining system described above is illustrated. Thecanister assembly includes an open topped canister body 222 with asidewall 256 and a base 266. The canister body houses an internalseparator element 238 in the form of a funnel that extends downwardlyinto spout 276 passing through the base of the canister body andterminating in a tissue retrieval or collection port 230. An internalcircumferential ledge 231 has been added to accommodate the rim 272 ofthe separator funnel 238 which nests atop the ledge. The ledge alsoassists in aligning the funnel within the canister body. As with theprior embodiment, the funnel sub-divides the canister body into an uppervacuum chamber 240 and a lower vacuum chamber 242. The bottom surface266 of the canister body curves gently upwardly from the outer sidewalls 256 of the canister body forming a circumferential gutter 257surrounding a central collection port. As the fluid level drops in thelower vacuum chamber, the gutter assists in pooling fluids away from thecentral port and toward the outer wall 256 of the canister body.

As with the prior embodiment, the funnel, catch, or cradle 238 includesa set of fenestrations (or windows or apertures) 244 (such as thoseshown in FIGS. 6-7 for example) for allowing fluid to pass through butpreferably retaining the fatty (adipose) tissue 236 on the top surface268 of the funnel. In this exemplary embodiment, the ring of funnelapertures is positioned at a fixed height in the canister body relativeto the upper rim 258 of the canister body 222. As further shown in FIG.17, the funnel includes a drain tube aperture 284 providing a passagethrough which an evacuation tube 286 may pass. In this exemplaryembodiment, the drain tube aperture is larger in diameter than theevacuation tube. The drain tube aperture is at least partially definedby a vent spout 261 that projects upwardly from the upwardly facingsurface 268 of the funnel 238. This vent spout includes a passagewayconnecting the upper vacuum chamber 240 to the lower vacuum chamber 242and is used to control the pressure equilibrium between the two chambersduring the drain procedure described below.

Still referring to FIG. 17, a lid 262 for covering the open toppedregion of the canister body 222 is modified from the lid 62 describedabove. The overflow shutoff valve 110 (FIGS. 8-9) has been removed ashas the off-center auxiliary fill port and cap 102. In its place, thelid 262 includes an enlarged central opening 292 providing a fill portthat may be capped off with a circular cap 302. The central circular capincludes a vacuum port 224 and a circumferential rim 293 that may besnap fit onto the flange 295 extending upwardly from the lid. A threadedcoupling between the circular cap and lid or other suitable couplingmeans to releasably secure the cap to the lid may used alternatively.The lid further includes a tissue harvesting port 228 that may becoupled to a conventional tissue harvesting device 55 as represented inFIG. 16A. A tissue harvesting port cap 300 covers the port when not inuse. The evacuation or drain port 226 opposes the tissue harvesting porton the lid. All three ports (224, 226, and 228) are spaced apart on thelid and circular cap assembly. Each of the ports includes an upwardlyprojecting (as shown in FIG. 17) tube mounting stub 225, 227 and 229,respectively, and provides a respective passage from outside thecanister body to the upper vacuum chamber 240 through the lid or centralcap 302. The lid includes a peripheral mounting flange 259 for snapfitting onto the uppermost rim 258 of the canister body 222.

The lid 262 is further coupled to a fluid manifold, generally designated340, for coupling the canister assembly 220 inline with the wastecanister 52 (FIG. 16A and vacuum source 32 (FIG. 16A) as describedabove. The fluid manifold includes a Y-shaped connector with a first leg342 coupled to the vacuum port 224 and a second leg 344 coupled to thedrain port 226. The free end 350 at the end of the central extension 348of the Y-connector may be coupled to the waste canister or vacuum sourceas described above for the prior embodiment using conventional hoses,tubing, clamps, and the like.

With continued reference to FIG. 17, the first leg 342 of the vacuum andfluid manifold 340 includes a pinch clamp 356 mounted thereon as analternative to the valve 156 described above. The pinch clamp providesadditional control of the vacuum within the canister body 222 and upperand lower vacuum chambers 240 and 242, respectively. The pinch clamp isslide mounted on the first leg and may generally be set in an openposition as shown in FIG. 17 with the passage through the first leg 342of the vacuum and fluid manifold completely open. The fully openposition is preferably used during the tissue harvesting procedure toproduce a vacuum in the upper vacuum chamber 240 so that a tissueharvesting device 55 (FIG. 16A) may be used to retrieve tissue from apatient site and deliver the harvested tissue to the upper vacuumchamber 240 of the canister body 222 when the free end 350 is coupled toan activated vacuum source.

The pinch clamp 356 may also be set in fully closed position pinchingoff or closing the passageway through the first leg 342 and isolatingthe upper vacuum chamber 240 from the vacuum source 32 (FIG. 16A) whileleaving the second leg 344 open. Closing the pinch clamp during thedraining procedure when the fluid and vacuum manifold 340 is coupled toan activated vacuum source 32 (FIGS. 16A-B) effectively isolates theupper vacuum chamber 240 from the vacuum source. Additionally, the pinchclamp may be positioned at an incremental setting between the fully openand fully closed position to further control the evacuation rate ofbilge fluid or retrieval rate of harvested tissue. A maximum evacuationrate is reached, however, when the pinch clamp on the first leg andharvest port are both fully closed.

In addition to the upwardly projecting tube stub 227, the evacuation ordrain port 226 further includes an inwardly projecting drain tubemounting stub 233 for securing the upper end of the evacuation tube 286.The upper end of the evacuation tube slip fits inside the inner wall ofthe drain tube mounting stub. From the drain tube mounting stub, theevacuation tube 286 extends downwardly and passes through the vent tubespout 261 and drain tube aperture 284 to dispose the lower end 306 ofthe drain tube in the lower vacuum chamber 242 or bilge area beneath theundersurface 270 of the perforated funnel and proximate the bottom wall266 of the canister body 222 and within the gutter region 257, which isthe lowest point of the interior of the canister body. The drain tubeprovides a passage 263 to the drain port 226 and thus from outside thecanister body to the bilge area 242 of the canister body beneath thefunnel 238. In this exemplary embodiment, the lower end 306 of the draintube 286 is spaced approximately one-eighth to three-sixteenths off thebottom wall 266 of the canister body to capture as much bilge fluid aspossible without getting clogged up. This gap between the lower end ofthe drain tube and the bottom wall or floor 266 of the canister body isnot meant to be limiting however.

A vent tube 277 has been added to this canister assembly 220 forproviding an alternative pressure control feature of the tissue refiningsystem. The vent tube is concentrically mounted around the drain tube286. In this exemplary embodiment, the vent tube has an outer diameterof half an inch while the outer diameter of the drain tube isone-quarter of an inch. The inner diameter of the vent tube isthree-eighths of an inch providing a vent path 279 between the vent tubeand drain tube. The vent tube is essentially a loose fitting sleeve overthe drain tube with the lower end 275 of the vent tube coupled to thevent tube spout 261 on the funnel. In FIG. 17, the upper end 281 of thevent tube stops short of the inner surface 308 of the lid and forms anopening 283 into the upper vacuum chamber. These openings are preferablyabove the upper fluid line 295 of the fluid bath and harvested tissuemixture but it will be appreciated that an opening into the upper vacuumchamber that will not be blocked when the fatty tissue settles onto thefunnel will suffice as well. This construction maintains a passageway279 from the lower vacuum chamber 242 or bilge area to the upper vacuumchamber 240. During a portion of the procedure, this passageway 279 maybe filled, with fluid as during the initial fill process. However, asthe fluid level 295 drops below the bottom end of the vent tube (theuppermost portion of the funnel drain tube aperture 284), the fluid isdrained and an air passage forms between the upper and lower vacuumchambers through the vent tube. This additional venting provisionassists in improved control over the vacuum levels within the respectivevacuum chambers as will be described below.

Another alternative of the vent tube is shown in FIG. 18. In thisexemplary embodiment, the vent tube 377 extends all the way to theundersurface 308 of the lid 262 and is coupled to the exterior surfaceof the inwardly projecting tube mounting stub 233 using a slip fit. Thevent tube is perforated with a pair of opposing vent holes 383 and 385to create a vent passage 379 from the lower vacuum chamber 240 to theupper vacuum chamber 240. Operation of both vent tube alternatives isthe same with the second version in FIG. 18 better securing the upperend 381 of the vent tube.

Referring now to FIGS. 1 and 12-18, the operation of the canisterassembly 220 as used with the tissue refining system 50 generally shownin FIGS. 16A-D will now be described. Much of the operation between thetissue separating apparatus 20 and the canister assembly 220 is thesame. Differences in operation will be pointed out as the process isdescribed below. In operation, assuming as a starting point that theentire assembly of the canister body 222, lid 262, drain and vent tubes286 and 277, central cap 302, and vacuum and fluid manifold 304 may becontained in a sterile package like a kit, the package is opened toallow access to the canister assembly components. After opening thepackage, the canister body 222 with separator funnel 238 of the canisterassembly 220 may be set within a holding tray platform 181 as in FIG. 1.The lid 262 may be snap fit onto the rim 258 of the canister bodythereon to seal off the top opening of the canister body. The tissueharvesting syringe 54 (FIGS. 1 and 15) is coupled to the tissueharvesting port 276 of the funnel as in the prior embodiment. Theplunger 170 is depressed fully and the pinch clamp 174 is set in theclosed position to pinch off the harvesting tube 172. The central cap302 may then be removed by the user and a volume of solution, wash, orfluid bath 294 as in the first embodiment may be added to the canisterbody through the fill port 292 filling up to a fluid line 295 determinedby the user. Once the fluid bath is added, the user secures the centralcap on the lid using the snap fit between the two components. It will beappreciated that, at this point, the fluid bath may enter the drain tubepath 263 as well as the vent path 279 obstructing the flow of airbetween the upper vacuum chamber 240 and lower vacuum chamber 242.

The vacuum and fluid manifold 340 may then be coupled to the lid 262 asfollows. The vacuum control pinch clamp 356 is slid onto the first leg342 of the manifold. The first leg is coupled to the vacuum port 224while the second leg 344 may be coupled to the drain port 226.Respective caps are removed before hand if necessary. The pinch clamp356 remains in the open position initially. The free end 350 of they-connector is coupled to the vacuum source 32 (FIGS. 1 and 16A-B) viathe waste canister 52 as in the prior embodiment.

With the tissue refining system set up, the tissue harvesting process isthe same as for the prior embodiment with the exception that the pinchclamp 356 is used and remains open on the first leg 342 of the vacuumand fluid manifold 340 instead of the two-position switch valve 156(FIG. 1) with the vacuum source activated. With a desired amount ofharvested tissue 236 in the upper vacuum chamber 240 of the canisterbody 222, the pinch clamp 356 may be closed to terminate the harvestingprocess. The tissue harvesting device 55 (FIG. 1) may be decoupled fromthe tissue harvesting port 228 and the tissue harvest port cap 300replaced on the tissue harvesting port. Alternatively, the tissueharvesting device may remain coupled to the tissue harvesting port.However, it is preferable to use a closed pinch clamp on the tubingbetween the tissue harvesting port and the harvesting device to maximizefluid flow during the draining process.

At this point, an amount of harvested tissue 236 and other harvestedfluid and matter is immersed within the fluid bath 294 of the canisterbody. It will be appreciated that the added harvested tissue will raisethe upper fluid line 295. As before, the surgeon allows the fatty tissue236 to separate from the other fluids and matter until satisfied withthe separation status. In addition to washing the fatty tissue, thefluid bath helps clean and separate the fatty tissue, which tends tofloat, from the extraneous, undesired fluids. The vacuum source 32 maybe turned off during this part of the routine. Typically, the uppervacuum chamber returns to atmospheric pressure.

After allowing the fatty tissue to separate somewhat with the fattytissue 236 floating atop the fluid bath 294 and bilge fluids 237 in thebilge chamber 242, the surgeon or surgeon's assistant may elect toinitiate the draining procedure to further separate the fatty tissue 236from the fluid bath 294 and bilge fluid 237. The vacuum control pinchclamp 356 is squeezed to a closed position to seal off the upper vacuumchamber 240 and divert the vacuum to the lower vacuum chamber 242through the drain tube 286 once the vacuum source 32 (FIG. 16A) isactivated. Under negative vacuum pressure, the bilge fluid 237 that haspassed through the openings 244 in the funnel 286 into the lower vacuumchamber will rise through the drain tube 286 through the second leg 344of the vacuum and fluid manifold 340 and on into the waste canister 52(FIGS. 16A-C) coupled inline with the canister body 222. As more fluiddrains from the upper vacuum chamber 240 into the bilge chamber 242 andon through the drain tube 286 to the waste canister 52, the fatty tissue236 settles onto the upper surface 268 of the funnel 238 and willtypically block the funnel openings 244 similar to that scenario shownin FIG. 14. The upper fluid line 295 has also dropped below the opening284 in the lower end 275 of the vent tube 277 exposing the vent path 279such that an air passage forms between the upper vacuum chamber 240 andthe lower vacuum chamber 242. This event generally coincides with thefatty tissue blocking off the funnel apertures 244. The opening of theair passage between the upper and lower vacuum chambers helps toequalize the pressure between the two chambers. This has the benefit ofreducing or eliminating the suction force on the fatty tissue resting onthe funnel and covering the apertures 244 which reduces the trauma tothe fatty tissue. In addition, some residual fluid that remains abovethe funnel may drip down into the bilge chamber 242 under gravitationalforces to more thoroughly separate the fatty tissue from the otherfluids that are small enough to pass through the funnel openings.

In addition, while much of the bilge fluid 237 has been drained out ofthe canister body, there will remain residual bilge fluid in the bilgearea 242. In the prior embodiment, this excess residual bilge fluidresiding beneath the funnel and beneath the lowermost end 106 (FIG. 4)of the drain tube would be removed manually using the tissue harvestingsyringe 54 as explained above. Because of the potential trauma to thefatty tissue, the draining procedure was typically terminated prior toremoving all of the bilge fluid.

However, in this embodiment, the addition of the vent tube 277 allowsthe user to continue to draw fluid from the bilge chamber 242 morethoroughly draining the canister body 222. Without the vent tube as inthe prior embodiments, once the fatty tissue 236 settles onto the funnel238 and covers the funnel openings 244, the suction created in the lowervacuum chamber will begin to act upon the fatty tissue, which isundesirable as some of the fatty tissue may be pulled through the funnelopenings as the drain tube position coupled to the vacuum sourcecontinues to produce negative pressure in the lower vacuum chamber.

In the present embodiment (FIGS. 17-18) with the vent tube 277, a vacuumbreak is created in use that allows for a more thorough draining of thebilge fluid 237 without undue stress on the fatty tissue blocking theopenings in the funnel. More specifically, when the initial fluid bathis added to the canister body, the fluid bath 294 will fill the bilgearea 242, a portion of upper vacuum chamber 240 above the funnel 238 andalso a portion of the vent tube 277 surrounding the drain tube 286 asshown in FIG. 17. When fatty tissue and other harvested tissue is addedto the upper vacuum chamber this upper fluid line 295 rises. The fluidprevents air from passing between the upper vacuum chamber to the bilgearea through the vent tube passageway 279.

Once the lower vacuum chamber 240 is placed in communication with thevacuum source 32 through the drain tube 286, the fluid begins to drainout of the bilge chamber 242 through the drain tube 286 and into thewaste canister 52 (FIG. 16A). The lower pressure introduced into thelower vacuum chamber 242 results in the bilge fluid 237 exiting thecanister body through path 263 in the drain tube 286. This lowers theoverall fluid level within the canister body 222. As the fatty tissue236 was allowed to separate (float to the top of the harvested and fluidbath mixture), the lowermost fluid is drained out first through thelowermost end 306 of the drain tube. This lowermost fluid is typicallythe fluid bath and other harvested fluids other than the fatty tissue.At first, the drained fluid comes from fluid that first settled in thebilge area. As more and more bilge fluid 237 is removed from the bilgechamber, additional fluid from above the funnel 238 passes through thefunnel and settles in the bilge 242 becoming bilge fluid. This new bilgefluid is also drained out of the canister body. The fatty tissuecontinues its descent down the canister body toward the top surface 268of the funnel.

The draining of the bilge fluid 237 continues as before until the fluidlevel drops below the bottom edge of the vent tube 277. At that point,there is no more fluid inside the vent tube and an air passage 279 isformed between the upper vacuum chamber 240 above the funnel 238 and thelower vacuum chamber 242 below the funnel. The fatty tissue 236 alsostarts settling on the holes 244 in the funnel effectively creating aseal between the upper and lower vacuum chambers. In the priorembodiment, the pressure differential between the lower vacuum chamberand the upper vacuum chamber continued to draw the fatty tissue throughthe holes in the funnel resulting is sometimes damaging the fattytissue.

This vent path 279 relieves the pressure differential between the upperand lower vacuum chambers 240 and 242, respectively. However, eventhough the bilge fluid level has fallen below the vent tube 277, thereremains bilge fluid 237 in the bilge chamber 242. It is preferable todrain out as much of this remaining bilge fluid as possible. In thisexemplary embodiment, it is possible to do so as the lowermost end 306of the drain tube 286 remains submerged below the bilge fluid levelwhich remains under vacuum from the vacuum source 32. Thus, the bilgefluid may continue to drain under vacuum through the lowermost end ofthe drain tube that is still submerged into the bilge fluid. However, itwill be appreciated that due to a vacuum break between the upper andlower vacuum chambers created by the vent tube, the vacuum pressureexerted on the fatty tissue blocking the holes 244 in the funnel 238 isremoved and thus the fatty tissue 236 is treated more gently. The vacuumbreak results from the ease of drawing air from the upper vacuum chamberthrough the vent tube 277 over the difficulty of pulling the viscousfatty tissue through the holes in the funnel. In addition, any residualfluid that is not fatty tissue will continue to drain into the bilgechamber under gravity where such fluid will pool in the gutter 257 andcan be sucked out through the drain port. It will be noted that asimilar result may be gained with the pinch clamp 356 partially closedduring the draining process. However, this generally results in amixture of air entering the drained fluids creating a sputtering orspitting effect into the waste canister. Such fluid is typically moreagitated and reduces the drain flow rate.

It will be appreciated the first embodiment works well in many scenariosbut the second embodiment offers a more consistent vacuum break andimproved bilge drainage feature through the introduction of the venttube 277. This features allows for a more thorough draining of the bilgearea 242 while presenting less vacuum force to the fatty tissue 236 thatsettles on and blocks the openings on the funnel. As more fluid istypically separated and drained from the fatty tissue, the yield ofuseful, highly concentrated, fatty tissue is improved.

Once the bilge area 242 is sufficiently drained, the user may engage thetissue collection syringe to remove any remaining bilge fluid 237 thatremains or has entered the line 172 (FIGS. 1 and 16C). It will beappreciated that such remaining bilge fluid will be significantly lessthan the first embodiment. The fatty tissue 236 resting atop the funnel238 may then be collected in the collection syringe 54 (FIG. 16D) asdescribed above for the first embodiment for storage or re-implantation.It will further be appreciated that the rate of drainage in the secondembodiment is typically faster than the drain rate in the firstembodiment under the same vacuum pressure.

The vacuum break created by the vent tube 277 is selected tosubstantially coincide with the fatty tissue 236 covering the holes 244in the funnel 238. As the vacuum attempt to pull the fatty tissuethrough the holes, the higher viscosity of the fatty tissue will createa back pressure that assists with the vacuum break which equalizes thepressure between the upper and lower vacuum chambers 240 and 242,respectively. The addition of vent tube allows the drain tube to extendfurther into the bilge area since the concern of tugging on the fattytissue is substantially removed or eliminated and thus more bilge fluidcan be removed. Such process also results in purer bilge fluid that maybe useful in gathering stem cells and the like for other procedures.

While the present invention has been described herein in terms of anumber of preferred embodiments, it will be appreciated that variouschanges, uses, and improvements may also be made to the inventionwithout departing from the scope and spirit thereof. Any numbers orranges are meant to be exemplary and not limiting.

For example, it will be appreciated that multiple separation canisters32 may be connected in series to harvest larger volumes of tissue 36. Inaddition, a dedicated vacuum source coupled to a corresponding vacuumport and evacuation port may be used. While this may eliminate the needfor a drain valve as the vacuum sources could be operatively turned onand off to control the harvesting and draining processes, sucharrangement is generally considered more cumbersome. In addition, whilethe evacuation port described herein is preferably located in thecanister lid, the drain port may appear at other locations on thecanister body as long as long as there is access to the bilge area.While the separation canister and related system and method describedherein is described in terms of a preferred one-valve system, additionalopen/closed valves may be used in the other vacuum lines and conduits orbuilt into the other ports as well to isolate or open the vacuum, tissueharvesting, and collection pathways.

It will also be appreciated that by constructing the separation canisterfrom plastic materials instead of the autoclave proof glass materialscommonly used for re-usable canisters, additional costs, for bothmaterials and cleaning, may be saved from the introduction of a one-usedisposable canister.

1. A tissue refining device for use with a harvesting instrument and avacuum source, the device comprising: a canister body with an open topregion and a base including a tissue retrieval port; a lid constructedto releasably engage the canister body and cover the open top region,the lid further including a vacuum port and a drain port operable to beplaced in communication with the vacuum source, a tissue harvesting portoperable to be placed in communication with the harvesting instrumentand to direct a quantity of tissue retrieved by the harvestinginstrument into the canister body when suction is applied to the vacuumport by the vacuum source; a separator element sub-dividing the canisterbody into an upper vacuum chamber in communication with the vacuum portand the tissue harvesting port and a lower vacuum chamber incommunication with the drain port, the separator element including atleast one aperture projecting through the separator element and adepression with a channel in communication with the tissue retrievalport; a drain tube projecting into the canister body from the evacuationport of the lid and having a lower end extending through the separatorelement and disposed within the lower vacuum chamber; and a vent passagebetween the upper vacuum chamber and the lower vacuum chamber operableto enable airflow between the two chambers when a fluid level within thecanister body drops below a predetermined level, the vent passagefurther being operable to trigger a vacuum break when a sufficientamount of the quantity of tissue settles on the separator element andcovers the at least one aperture.
 2. The device as set forth in claim 1wherein: the vent passage is in the form of a vent tube, concentricallyarranged with at least a portion of the drain tube, the vent tube beingoperable to equalize the pressure between the upper vacuum chamber andthe lower vacuum chamber when an air passage is formed therebetween. 3.The device as set forth in claim 2 wherein: the vent tube includes anuppermost opening located above the at least one aperture on theseparator element.
 4. The device as set forth in claim 2 wherein: thevent tube attaches to the inside of the lid and includes at least onevent opening into the upper vacuum chamber.
 5. The device as set forthin claim 2 wherein: the vent tube is co-extensive with at least aportion of the drain tube.
 6. The device as set forth in claim 1wherein: the base of the canister body includes a gutter region forpooling fluids draining into the lower vacuum chamber and the lower endof the drain tube resides above and in close proximity with the gutterregion.
 7. The device as set forth in claim 1 further comprising: avacuum manifold having a free end operable to be coupled with the vacuumsource, a first branch in communication with the vacuum port, and asecond branch in communication with the evacuation port and having anactuator constructed to selectively isolate the evacuation port from thevacuum source when the manifold is coupled thereto.
 8. The device as setforth in claim 1 further including: a syringe in communication with thetissue retrieval port and operable to withdraw a selected quantity oftissue settled onto an upper surface of the separator element throughthe tissue retrieval port.
 9. The device as set forth in claim 1wherein: the lid includes a removable cap releasably engageable with thelid and including the vacuum port whereby the removable cap may beremoved for adding a quantity of wash fluids into the canister body. 10.A tissue refining device for use with a harvesting instrument and avacuum source, the device comprising: a canister body with an open topregion and a base including a tissue retrieval port; a lid constructedto releasably engage the canister body and cover the open top region,the lid further including a vacuum port and a drain port operable to beplaced in communication with the vacuum source, a tissue harvesting portoperable to be placed in communication with the harvesting instrumentand to direct a quantity of tissue retrieved by the harvestinginstrument into the canister body when suction is applied to the vacuumport by the vacuum source; a separator element sub-dividing the canisterbody into an upper vacuum chamber in communication with the vacuum portand the tissue harvesting port and a lower vacuum chamber incommunication with the drain port, the separator element including atleast one aperture projecting through the separator element and adepression with a channel in communication with the tissue retrievalport; a drain tube projecting into the canister body from the evacuationport of the lid and having a lower end extending through the separatorelement and disposed within the lower vacuum chamber; and a vent passagebetween the upper vacuum chamber and the lower vacuum chamber andincluding a lowermost opening positioned above the at least one aperturein the separator element within the canister body when in an uprightposition, the vent passage being operable to enable airflow between thetwo chambers when a fluid level within the canister body drops below apredetermined level.
 11. A tissue refining device for use with aharvesting instrument and a vacuum source, the device comprising: acanister body with an open top region and a base including a tissueretrieval port; a lid constructed to releasably engage the canister bodyand cover the open top region, the lid further including a vacuum portand a drain port operable to be placed in communication with the vacuumsource, a tissue harvesting port operable to be placed in communicationwith the harvesting instrument and to direct a quantity of tissueretrieved by the harvesting instrument into the canister body whensuction is applied to the vacuum port by the vacuum source; a separatorelement sub-dividing the canister body into an upper vacuum chamber incommunication with the vacuum port and the tissue harvesting port and alower vacuum chamber in communication with the drain port, the separatorelement including at least one aperture projecting through the separatorelement and a depression with a channel in communication with the tissueretrieval port; a drain tube projecting into the canister body from theevacuation port of the lid and having a lower end extending through theseparator element and disposed within the lower vacuum chamber; and avent passage between the upper vacuum chamber and the lower vacuumchamber and including an uppermost vent opening to the upper vacuumchamber positioned proximate the evacuation port on the lid, the ventpassage being operable to enable airflow between the two chambers when afluid level within the canister body drops below a predetermined level.12. The device as set forth in claim 1 wherein: the vent passage mayinitially be filled with fluid when the canister body is at leastpartially filled above the separator element but may form an air passagetherein as a quantity of tissue settles onto the separator element toblock the at least one aperture whereby air may flow between the upperand lower vacuum chambers.
 13. A tissue refining device for use with aharvesting instrument and a vacuum source, the device comprising: acanister body with an open top region and a base including a tissueretrieval port; a lid constructed to releasably engage the canister bodyand cover the open top region, the lid further including a vacuum portand a drain port operable to be placed in communication with the vacuumsource, a tissue harvesting port operable to be placed in communicationwith the harvesting instrument and to direct a quantity of tissueretrieved by the harvesting instrument into the canister body whensuction is applied to the vacuum port by the vacuum source; a separatorelement sub-dividing the canister body into an upper vacuum chamber incommunication with the vacuum port and the tissue harvesting port and alower vacuum chamber in communication with the drain port, the separatorelement including at least one aperture projecting through the separatorelement and a depression with a channel in communication with the tissueretrieval port; a drain tube projecting into the canister body from theevacuation port of the lid and having a lower end extending through theseparator element and disposed within the lower vacuum chamber; and avent passage between the upper vacuum chamber and the lower vacuumchamber operable to enable airflow between the two chambers when a fluidlevel within the canister body drops below a predetermined level, thevent passage is being responsive to a back pressure created when asufficient amount of the quantity of tissue settles on the separatorelement and covers the at least one aperture to equalize the twochambers.
 14. The device as set forth in claim 7 wherein: the actuatoris a pinch clamp.